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RegisterWhat's the problem? [Regulatives / Guidelines]
PS: No, I don't think that assay performance will do anything to intraindiv. CV of a drug product, as long as
- not practically all samples are around LLOQ
- effects are not random.
Did some sims in the old daysTM, effect of assay when validated according to current recommendations is negligible.
Especially for the "11% CV in 5 other trials, suddenly 40% in my trial" example there is no explanation remotely related to assay.
- not practically all samples are around LLOQ
- effects are not random.
Did some sims in the old daysTM, effect of assay when validated according to current recommendations is negligible.
Especially for the "11% CV in 5 other trials, suddenly 40% in my trial" example there is no explanation remotely related to assay.
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Highly Variable Drug BE Justification jag009 2017-03-20 04:42 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
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- What's the problem? DavidManteigas 2017-05-17 11:25
- What's the problem?nobody 2017-05-17 09:31
- What's the problem? nobody 2017-05-17 07:48
- Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
- Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
- Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
- Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
- Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
Ing. Helmut Schütz